Healthy VolunteersNCT01306318
A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)
A study testing eperisone hydrochloride plus diclofenac sodium capsule and eperisone hydrochloride tablet and diclofenac sodium tablet in people with Healthy Volunteers, run by Eisai Co., Ltd. at 1 site in India.
Trial summary
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- eperisone hydrochloride plus diclofenac sodium capsule and eperisone hydrochloride tablet and diclofenac sodium tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy human adult male volunteers between 18-45 years (both ages inclusive) of age, who have given written informed consent and are willing to participate in the study.
- Volunteer having Body Mass Index of 18.50 to 24.90 Kg/m2 (both inclusive).
- Volunteer with no evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study
- Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his participation in the study.
- Volunteer with negative test for alcohol and drugs of abuse, hepatitis B and C and who is negative or nonreactive for antibodies to human immunodeficiency virus (HIV) 1 and 2 and rapid plasma reagin (RPR).
- Volunteer having a 12 lead electrocardiogram (ECG) recording within normal limits.
- Volunteer with normal chest X-ray taken within 6 months before the day of dosing.
- Volunteer will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
Who cannot join
- Volunteer who is allergic to eperisone and/or diclofenac or any component of the formulation and to any other related drug.
- Volunteer with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- More specifically, volunteer with history or presence of the following significant conditions:
- Alcohol dependence, alcohol abuse or drug abuse within the past one year, recent or current alcohol abuse (> 5 units/week, 1 unit= 10 mL or 8 g of pure alcohol) or suspected abuse.
- History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.
- Asthma, urticaria or other allergic type reactions after taking any medication.
Show all 21Show fewer
- Clinically significant illness within 4 weeks before the start of the study.
- Hypersensitivity to heparin.
- History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
- History of Vascular collapse.
- Volunteer who is scheduled for surgery within 7 days after study completion.
- Volunteer who, through completion of any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
- Volunteer who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin) within 14 days prior to administration of IP in period 1, including topical medication meant for systemic absorption.
- Volunteer who was hospitalized within 28 days prior to administration of the study medication.
- Volunteer with pulse rate less than 60/min or more than 100/min.
- Volunteer with history of difficulty in swallowing.
- Volunteer who has unsuitable veins for repeated venipuncture.
- Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study.
- Volunteer who has
- Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
Trial locations and contacts
1 site in 1 country.
India1 site
Manipal AcuNova KH Clinical Research Center
Manipal, Karnataka, 576 104
About this study
Official title: A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects under fasting conditions.
Read the detailed description
The primary objective of this study is to compare the single-dose oral bioavailabilities of eperisone and diclofenac from Epry-D (containing eperisone hydrochloride 50 mg and diclofenac sodium 50 mg) capsules of Eisai Pharmaceuticals India Private Limited, India with those from Epry (eperisone hydrochloride) 50 mg tablets of Eisai Pharmaceuticals India Pvt. Ltd., and voltaren (diclofenac sodium) 50 mg tablets of Novartis Pharmaceuticals Ltd., India in healthy human adult male subjects under fasting conditions. The secondary objective of this study is to monitor the safety and tolerability of a single dose of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg formulation when administered in healthy human adult male subjects under fasting conditions. The participants will be screened for demographic data, medical history, general physical examination, 12-lead electrocardiogram (ECG), chest X-ray (Posterior to Anterior view), hematology, clinical bio- chemistry, serology, urine analysis, tests for alcohol and drugs of abuse. A total of 24 healthy adult male volunteer participants will be housed in the clinical study facility at least 11 hours before administration of the Investigational Product (IP) and will continue to remain in the clinical study facility for at least 12 hours after administration of the IP in each study period. After overnight fasting for at least 10 hours, either one Epry-D capsule or one Epry 50 mg tablet and one Voltaren 50 mg tablet will be administered orally to each participant in sitting posture, with 240 plus or minus 2 mL of water at room temperature, in each study period, as per the randomization schedule. Administration of the IP will be performed by trained study personnel. Dosing activity will be followed by mouth check to assess the compliance to dosing. A total of 22 (6 mL) blood samples will be collected from each subject in pre-specified vacuum tubes containing K2 EDTA in each study period.
- Conditions
- Healthy Volunteers
- Being tested
- eperisone hydrochloride plus diclofenac sodium capsule, eperisone hydrochloride tablet and diclofenac sodium tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eperisone hydrochloride plus diclofenac sodium capsuleDrug
Single dose of fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given in healthy volunteers in fasting conditions
eperisone hydrochloride tablet and diclofenac sodium tabletDrug
Single dose of eperisone hydrochloride 50 mg as tablet formulation and diclofenac sodium 50 mg as tablet formulation to be given in healthy volunteers in fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: eperisone hydrochloride plus diclofenac sodium capsule |
| 2 | Active comparator | Not described Receives: Drug: eperisone hydrochloride tablet and diclofenac sodium tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral bioavailabilities: Maximum Concentration (Cmax) of eperisone and diclofenac fixed dose capsules versus eperisone & diclofenac tablets
Compare single-dose oral bioavailabilities (Cmax) of eperisone and diclofenac fixed dose capsules with eperisone \& diclofenac tablets. Cmax is defined as the maximum observed concentration in plasma.
Measured: 12 hours post dose
Secondary outcomes (1)
Safety & tolerability (total number of subjects reporting adverse events) of single dose of fixed dose combination of eperisone and diclofenac in fasting conditions
Safety \& tolerability measured as total number of participants reporting adverse events of single doses and fixed dose combination of eperisone and diclofenac in fasting conditions.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suyog Mehta, Study director, General Manager Medical & Regulatory Affairs, Eisai Pharmaceuticals India Private Limited, Mumbai, MS, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306318
- Sponsor's protocol ID
- 013-10
- Status last verified
- Nov 2015
- First submitted
- 24 Feb 2011
- Last updated
- 17 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01306318
- Acronym / sponsor ID
- 013-10
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects under fasting conditions.
Detailed description
The primary objective of this study is to compare the single-dose oral bioavailabilities of eperisone and diclofenac from Epry-D (containing eperisone hydrochloride 50 mg and diclofenac sodium 50 mg) capsules of Eisai Pharmaceuticals India Private Limited, India with those from Epry (eperisone hydrochloride) 50 mg tablets of Eisai Pharmaceuticals India Pvt. Ltd., and voltaren (diclofenac sodium) 50 mg tablets of Novartis Pharmaceuticals Ltd., India in healthy human adult male subjects under fasting conditions. The secondary objective of this study is to monitor the safety and tolerability of a single dose of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg formulation when administered in healthy human adult male subjects under fasting conditions. The participants will be screened for demographic data, medical history, general physical examination, 12-lead electrocardiogram (ECG), chest X-ray (Posterior to Anterior view), hematology, clinical bio- chemistry, serology, urine analysis, tests for alcohol and drugs of abuse. A total of 24 healthy adult male volunteer participants will be housed in the clinical study facility at least 11 hours before administration of the Investigational Product (IP) and will continue to remain in the clinical study facility for at least 12 hours after administration of the IP in each study period. After overnight fasting for at least 10 hours, either one Epry-D capsule or one Epry 50 mg tablet and one Voltaren 50 mg tablet will be administered orally to each participant in sitting posture, with 240 plus or minus 2 mL of water at room temperature, in each study period, as per the randomization schedule. Administration of the IP will be performed by trained study personnel. Dosing activity will be followed by mouth check to assess the compliance to dosing. A total of 22 (6 mL) blood samples will be collected from each subject in pre-specified vacuum tubes containing K2 EDTA in each study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eperisone hydrochloride plus diclofenac sodium capsule |
| 2 | Active comparator | Drug: eperisone hydrochloride tablet and diclofenac sodium tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Normal healthy human adult male volunteers between 18-45 years (both ages inclusive) of age, who have given written informed consent and are willing to participate in the study.
- Volunteer having Body Mass Index of 18.50 to 24.90 Kg/m2 (both inclusive).
- Volunteer with no evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study
- Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his participation in the study.
- Volunteer with negative test for alcohol and drugs of abuse, hepatitis B and C and who is negative or nonreactive for antibodies to human immunodeficiency virus (HIV) 1 and 2 and rapid plasma reagin (RPR).
Key exclusion criteria (21 listed)
- Volunteer who is allergic to eperisone and/or diclofenac or any component of the formulation and to any other related drug.
- Volunteer with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- More specifically, volunteer with history or presence of the following significant conditions:
- History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
- History of Vascular collapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eperisone hydrochloride plus diclofenac sodium capsuleSingle dose of fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given in healthy volunteers in fasting conditions | Drug | 1 |
| eperisone hydrochloride tablet and diclofenac sodium tabletSingle dose of eperisone hydrochloride 50 mg as tablet formulation and diclofenac sodium 50 mg as tablet formulation to be given in healthy volunteers in fasting conditions | Drug | 2 |
Primary outcome
Oral bioavailabilities: Maximum Concentration (Cmax) of eperisone and diclofenac fixed dose capsules versus eperisone & diclofenac tablets
Time frame: 12 hours post dose
Compare single-dose oral bioavailabilities (Cmax) of eperisone and diclofenac fixed dose capsules with eperisone \& diclofenac tablets. Cmax is defined as the maximum observed concentration in plasma.
1 secondary outcome
Safety & tolerability (total number of subjects reporting adverse events) of single dose of fixed dose combination of eperisone and diclofenac in fasting conditions
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suyog Mehta study director
General Manager Medical & Regulatory Affairs, Eisai Pharmaceuticals India Private Limited, Mumbai, MS, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eperisone hydrochloride plus diclofenac sodium capsule and eperisone hydrochloride tablet and diclofenac sodium tablet in people with Healthy Volunteers, run by Eisai Co., Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral bioavailabilities: Maximum Concentration (Cmax) of eperisone and diclofenac fixed dose capsules versus eperisone & diclofenac tablets (time frame: 12 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.